阿斯利康的目标是向FDA提交非美国疫苗数据
AstraZeneca aims to bring non-U.S. vaccine data before the FDA

AstraZeneca aims to bring non-U.S. vaccine data before the FDA

阿斯利康的目标是向FDA提交非美国疫苗数据

11月5日(路透社)— 阿斯利康( ,简称阿斯利康)一旦从英国、南非和巴西获得了良好的试验数据,就会开始与美国监管机构讨论紧急批准其实验性COVID - 19疫苗的问题,因为它没有迹象表明监管机构会偏向美国的数据。

如果阿斯利康在总共25 000多名志愿者的基础上,从这些试验中获得了第一次统计上可靠的功效和安全结果, 阿斯利康将向美国食品和药品管理局(FDA)提交这些结果,尽管美国正在进行的试验的任何读本都将在数月后完成。

执行团队成员梅内·潘加洛斯(Mene Pangalos)对路透社(Reuters)说, “如果你达到了这些门槛,我们将与他们进行对话。 ”

“林业发展局发出的信号是,他们对数据的期望是获得批准, ”他说。他还表示,林业发展局没有与美国监管机构谈论他们应该从哪里获得一些数据。(Ludwig Burger和Pushkala Aripaka报告; Mark Potter编辑)

Nov 5 (Reuters) - AstraZeneca will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data.

If and when AstraZeneca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the U.S. Food and Drug Administration (FDA) even though any read-out from an ongoing U.S. trial will be months later.

"If you hit those thresholds we are going to have a conversation with them," executive team member Mene Pangalos told Reuters.

"What the FDA has signalled is what their expectations of data are for an approval," he said, adding the company had not spoken to the U.S. watchdog about where they data should some from. (Reporting by Ludwig Burger and Pushkala Aripaka; Editing by Mark Potter)

Nov 5 (Reuters) - AstraZeneca will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data.

11月5日(路透社)— 阿斯利康( ,简称阿斯利康)一旦从英国、南非和巴西获得了良好的试验数据,就会开始与美国监管机构讨论紧急批准其实验性COVID - 19疫苗的问题,因为它没有迹象表明监管机构会偏向美国的数据。

If and when AstraZeneca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the U.S. Food and Drug Administration (FDA) even though any read-out from an ongoing U.S. trial will be months later.

如果阿斯利康在总共25 000多名志愿者的基础上,从这些试验中获得了第一次统计上可靠的功效和安全结果, 阿斯利康将向美国食品和药品管理局(FDA)提交这些结果,尽管美国正在进行的试验的任何读本都将在数月后完成。

"If you hit those thresholds we are going to have a conversation with them," executive team member Mene Pangalos told Reuters.

执行团队成员梅内·潘加洛斯(Mene Pangalos)对路透社(Reuters)说, “如果你达到了这些门槛,我们将与他们进行对话。 ”

"What the FDA has signalled is what their expectations of data are for an approval," he said, adding the company had not spoken to the U.S. watchdog about where they data should some from. (Reporting by Ludwig Burger and Pushkala Aripaka; Editing by Mark Potter)

“林业发展局发出的信号是,他们对数据的期望是获得批准, ”他说。他还表示,林业发展局没有与美国监管机构谈论他们应该从哪里获得一些数据。(Ludwig Burger和Pushkala Aripaka报告; Mark Potter编辑)